Trial Information
A Prospective, Multicentre, Controlled, Observational Study to Evaluate the Performance of Patient Support Programme (PSP) in Improving Patient Adherence With Adjuvant Aromatase Inhibitors (AI) Medication for Postmenopausal, Early Stage Breast Cancer
Inclusion Criteria:
- Provide signed and dated written Informed Consent
- Have been taking upfront AI adjuvant therapy in line with current SmPC
- Be capable of completing drug intake by herself
- Be capable of understanding Chinese
Exclusion Criteria:
- Upfront adjuvant hormonal therapy by an AI to which upfront adjuvant indication has
not been granted by SFDA
- Upfront adjuvant AI medication which has exceeded over eight weeks
- Previous adjuvant hormonal therapy for breast cancer lasting over 8 weeks other than
AI
- Involvement in the planning and conduct of the study (applies to both AstraZeneca
staff or staff at the study site)
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Outcome Measure:
compare the 1-year adherence
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Karen Atkin
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
China: Ethics Committee
Study ID:
NIS-OCN-ARI-2008/1
NCT ID:
NCT00769080
Start Date:
September 2008
Completion Date:
October 2010
Related Keywords:
- Breast Cancer
- PSP
- Standard Treatment
- Standard Treatment plus PSP
- Breast Neoplasms